# K061441: Ebi 5.5 Helical Flange Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 25, 2006 after 62 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
261 later devices descend from it; 9 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EBI® Array Spinal Fixation System/EBI® SpineLink II Spinal Fixation system with the VuePASS™ Portal Access Surgical System: named in the summary without a submission number
- (no number) EBI® Array Spinal Fixation System: named in the summary without a submission number
- (no number) EBI® Webb Morley Spine System: named in the summary without a submission number
- (no number) Interpore Cross International Synergy™ Spinal System (Posterior): named in the summary without a submission number
- (no number) Interpore Cross International Synergy Spinal System (Anterior): named in the summary without a submission number
- (no number) Medtronic Sofamor Danek CD HORIZON® Spinal System: named in the summary without a submission number

## Most influential descendants
- K081952: Synergy Spinal System (6.35 Polaris) (2008), 255 descendants of its own
- K090523: Polaris Spinal System (2009), 156 descendants of its own
- K090203: 5.5 Helical Flange Spinal System, Polaris Components (2009), 154 descendants of its own
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-2300-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
- Apr 2, 2009 · Not classified · Z-2301-2009: Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

## Indications for use
The 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The 5.5 Helical Flange Spinal System Percutaneous Instruments, when used with the 5.5 Helical Flange Spinal System cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications, regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., kyphosis, and lordosis), stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spiral System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications, regardless of intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients.

Source page: https://510kreport.com/device/K061441
Methodology: https://510kreport.com/methodology